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FDA 510(k)

BIO-CHEM ANALYZER, MODEL 100

K-Number: K040750 · 2004-10-28

ApplicantClinical Analysis Corporation, Inc.
Decision Date2004-10-28
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-CHEM ANALYZER, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Analysis Corporation, Inc.. It received FDA 510(k) clearance on 2004-10-28 under 510(k) number K040750. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-CHEM ANALYZER, MODEL 100?

BIO-CHEM ANALYZER, MODEL 100 is a medical device that received FDA 510(k) clearance on 2004-10-28. The listed applicant is Clinical Analysis Corporation, Inc.. The 510(k) number is K040750.

When did BIO-CHEM ANALYZER, MODEL 100 receive FDA 510(k) clearance?

BIO-CHEM ANALYZER, MODEL 100 received FDA 510(k) clearance on 2004-10-28, under 510(k) number K040750.

Who is the listed applicant for BIO-CHEM ANALYZER, MODEL 100?

The FDA 510(k) record lists Clinical Analysis Corporation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-CHEM ANALYZER, MODEL 100?

The FDA product code for BIO-CHEM ANALYZER, MODEL 100 is CEM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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